510(k) · Cleared
ClearedModification to Synthes Uss
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes Spine · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Mar 10, 2000 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Mar 10, 2000
- Review
- 28 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK000450 Modification to Synthes UssSynthes Spine · 2000
- Descendant · cites it directly · 11 of its ownK082353 Mercury Spinal SystemSpinal Elements, Inc. · 2009
- Descendant · cites it directly · 11 of its ownK083230 Mercury Spinal SystemSpinal Elements, Inc. · 2008
- Descendant · 2 generations on · 10 of its ownK091587 Mercury Spinal SystemSpinal Elements, Inc. · 2009
- Descendant · 2 generations on · 9 of its ownK141372 Mercury Spinal SystemSpinal Elements, Inc. · 2014
- Descendant · 2 generations on · 8 of its ownK151215 Mercury Spinal SystemSpinal Elements, Inc. · 2015
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K082353Mercury Spinal SystemSpinal Elements, Inc. · 2009 · cites it directly11descendants
- K083230Mercury Spinal SystemSpinal Elements, Inc. · 2008 · cites it directly11descendants
- K091587Mercury Spinal SystemSpinal Elements, Inc. · 2009 · 2 generations on10descendants
- K141372Mercury Spinal SystemSpinal Elements, Inc. · 2014 · 2 generations on9descendants
- K151215Mercury Spinal SystemSpinal Elements, Inc. · 2015 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000450 | Modification to Synthes Uss | Synthes Spine | 2000 | — |
| +1 | K082353 | Mercury Spinal System | Spinal Elements, Inc. | 2009 | — |
| +1 | K083230 | Mercury Spinal System | Spinal Elements, Inc. | 2008 | — |
| +2 | K091587 | Mercury Spinal System | Spinal Elements, Inc. | 2009 | — |
| +2 | K141372 | Mercury Spinal System | Spinal Elements, Inc. | 2014 | — |
| +2 | K151215 | Mercury Spinal System | Spinal Elements, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 143 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082353 (Spinal Elements, Inc., 2009) has gone furthest, with 11 descendants of its own.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K000450 · printed Nov 4, 2026
Cite this page
510(k) Report. “K000450: Modification to Synthes Uss.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000450
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026